IVC Filter Timeline
There are a lot of reports and milestones in the IVC filter lawsuits that are currently underway. The following is a timeline of the events surrounding IVC filters, manufacturers, and various research studies:
2003-2004: The FDA allows manufacturers to release the new permanent IVC filters with the option to retrieve into the marketplace through 510(K) clearance. Because the filters were allegedly similar to older models, the manufacturers did not have to undergo additional approval reviews. The Bard Recovery and G2 Filters and the Cook Medical Gunther Tulip and Celect are among the cleared devices.
2003: The Archives of Internal Medicine begins an 8 year study on the efficacy and side effects of IVC filters.
2005: The 510(K) clearance for the Bard Recovery filter is withdrawn, and Bard releases a second generation IVC filter, the G2.
2008: Bard’s third generation IVC filter, the G2 Express, is released. The Cook Medical Celect Filter is also cleared for the marketplace.
August 2010: The FDA releases a report documenting 921 separate adverse effects reported by patients implanted with permanent IVC filters with the option to retrieve. Of the 921 adverse events:
- 328 incidents involved the filter dislodging and migrating to other parts of the body.
- 146 events were embolizations (detachment of device components)
- 70 incidents involved the IVC filter or filter components perforating the vena cava vein.
- 56 reports were of the filter fracturing.
As a result of this study, the FDA released a warning that all physicians should remove these devices as soon as possible once protection from pulmonary embolism is no longer needed.
2011: The Archives of Internal Medicine release the results of the 8 year study. 203 patients diagnosed with acute venous thrombosis were given IVC filters. The study found that only 25% of these patients actually needed the filters. The study also discovered that out of a total of 679 implanted filters, only 58 of them were successfully retrieved. 18.3% of the retrieval attempts failed.
2012: By 2012, more than 200,000 IVC filters were being implanted in patients, each year. The market was forecasted to reach $435 million by 2015. Around this time, the first lawsuits against IVC filter manufacturers begin to emerge.
2014: The FDA releases yet another warning to manufacturers about the risks of long-term IVC filter treatment. This time, they strongly suggest that the filters be removed between 29-54 days after implantation if the patient’s transient risk for pulmonary embolism has passed.
2015: The lawsuits against Cook Medical are consolidated into an MDL (Multidistrict Lawsuit) before an Indiana judge. Similarly, cases against Bard are consolidated before an Arizona judge. Consolidation centralizes the jurisdiction for all lawsuits to avoid duplicate discovery processes and conserve resources. Essentially, it’s used when there are multiple claims of a similar nature.
2017: Bellwether trials scheduled for the Fall 2017.
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Martin, Harding & Mazzotti, LLP is an experienced personal injury firm with multiple offices across New York and Vermont. We concentrate in several areas of personal injury law, including defective devices and manufacturer negligence. We have the time and resources to handle cases against large entities such as the manufacturers of the IVC filters. Contact us today to learn more or to discuss your case.